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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOT APPLICABLE LASIK

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NOT APPLICABLE LASIK Back to Search Results
Event Date 04/20/2001
Event Type  Injury  
Event Description

After carefully researching existing lasik procedures and the available providers, i made an appointment for the initial evaluation. I had worn glasses since the age of 10, but was quite capable of getting around without them--my eyes were not that bad! during the exam, i was repeatedly asked if i had a problem with dry eyes to which i replied no. -understand, if one knows nothing but what is present, how could i know that my tear production was abnormal? i had never been able to wear contacts and, in hindsight, this was probably due to low tear production, but, other than this, i had no indication of this condition. It was not at a point that it was uncomfortable or debilitating. - i was approved for the procedure without reservation. During the procedure, the epithelium of my eye came off -both eyes-. A contact was put on to hold the tissue in place during the healing. I was more or less "blind" for the next 5 days. When removed, the epithelium was again loosened and the contact had to be replaced. The healing process was long and extremely uncomfortable. For the next month, i wore sunglasses almost constantly and my eyes are still sensitive to bright light. I have had 3 corneal erosions since then. I must put a thick gel in my eyes at night to keep them from drying out, resulting in another corneal erosion. I have tried drops, medicine -restasis-, supplements--all offer minimal relief. I have placed a humidifier in my house to try and further relieve the discomfort. While i do have 20/20 vision, i would gladly go back to wearing glasses in order to relieve this condition!.

 
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Brand NameNOT APPLICABLE
Type of DeviceLASIK
MDR Report Key1050087
Report NumberMW5006974
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/20/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 05/20/2008 Patient Sequence Number: 1
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